{"id":27775,"date":"2023-05-17T16:36:15","date_gmt":"2023-05-17T14:36:15","guid":{"rendered":"https:\/\/www.thema-med.com\/?page_id=27775"},"modified":"2023-06-30T10:09:54","modified_gmt":"2023-06-30T08:09:54","slug":"us-agent","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/es\/us-agent\/","title":{"rendered":"US Agent"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-justify-content-center fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_5_6 5_6 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:83.333333333333%;--awb-margin-top-large:15px;--awb-spacing-right-large:2.304%;--awb-margin-bottom-large:15px;--awb-spacing-left-large:2.304%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-image-element \" style=\"--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"1024\" height=\"576\" title=\"U.S. AGENT\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/U.S.-AGENT-1-1024x576.png\" alt class=\"img-responsive wp-image-28106\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/U.S.-AGENT-1-200x113.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/U.S.-AGENT-1-400x225.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/U.S.-AGENT-1-600x338.png 600w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/U.S.-AGENT-1-800x450.png 800w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/U.S.-AGENT-1-1200x675.png 1200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/U.S.-AGENT-1.png 1920w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 1200px\" \/><\/span><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:15px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><h2 class=\"fusion-responsive-typography-calculated\" style=\"text-align: center;\" data-fontsize=\"28\" data-lineheight=\"36.12px\"><span style=\"color: #000000;\">THEMA USA<\/span><br \/><span style=\"color: #000000;\">390 E 8th street, 4A<\/span><br \/><span style=\"color: #000000;\">New York, NY 10009 \u2013 U.S.A.<\/span><br \/><span style=\"color: #000000;\">info@themausa.net<\/span><\/h2>\n<\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-justify-content-center fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_2_3 2_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:66.666666666667%;--awb-margin-top-large:0px;--awb-spacing-right-large:2.88%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:2.88%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-2\"><p>En el mercado estadounidense de productos sanitarios y de diagn\u00f3stico in vitro, el papel del <a href=\"https:\/\/www.fda.gov\/medical-devices\/device-registration-and-listing\/us-agents\">U.S. Agent<\/a> es fundamental para todas las organizaciones extranjeras que participan en la fabricaci\u00f3n y distribuci\u00f3n de productos importados.<\/p>\n<p>De hecho, la FDA exige a las organizaciones con sede fuera de EE.UU. que deben mantener un <a href=\"https:\/\/www.fda.gov\/medical-devices\/device-registration-and-listing\/who-must-register-list-and-pay-fee\">registro de establecimiento<\/a> que designen a una persona de contacto con sede en EE.UU. a la que puedan dirigirse para cualquier comunicaci\u00f3n, sin tener que preocuparse por cuestiones de idioma o zona horaria.<\/p>\n<p><strong>Los datos de contacto<\/strong> del U.S. Agent son comunicados por la organizaci\u00f3n a trav\u00e9s del Sistema Unificado de Registro y Listado de la FDA (FURLS).<\/p>\n<p>A su vez, en un plazo de 10 d\u00edas laborables y de nuevo a trav\u00e9s del sistema FURLS, el U.S. Agent debe completar el proceso de confirmaci\u00f3n para actuar como representante de la organizaci\u00f3n.<\/p>\n<p>El U.S. Agent tiene las siguientes <strong>responsabilidades<\/strong>:<\/p>\n<ul>\n<li>Asiste a la FDA en las comunicaciones con la organizaci\u00f3n;<\/li>\n<li>Responde a las preguntas relativas a los productos importados en los Estados Unidos;<\/li>\n<li>Ayuda a la FDA a programar las inspecciones de los fabricantes.<\/li>\n<\/ul>\n<p>El U.S. Agent. no tiene responsabilidad alguna en la notificaci\u00f3n de acontecimientos adversos (21 CFR 803) ni en la presentaci\u00f3n de solicitudes 510(k) (21 CFR 807, Subparte E).<\/p>\n<p>El U.S. Agent debe ser <strong>\u00fanico<\/strong> para la organizaci\u00f3n: no se pueden designar diferentes U.S. Agent en funci\u00f3n de los productos importados.<\/p>\n<p>Por este motivo, conviene separar el proceso comercial del proceso reglamentario: <strong>Thema USA<\/strong>, la oficina de Thema en EE.UU., re\u00fane todas las caracter\u00edsticas necesarias para desempe\u00f1ar la funci\u00f3n de U.S. Agent, lo que hace que la organizaci\u00f3n sea independiente del importador y tenga libertad para comercializar los dispositivos cumpliendo plenamente la normativa de la FDA.<\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-3 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-3 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-padding-top:20px;--awb-padding-bottom:20px;--awb-padding-right-small:20px;--awb-padding-left-small:20px;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:10px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-3\" style=\"--awb-content-alignment:center;--awb-text-color:var(--awb-color1);\"><p>\u00bfDesea m\u00e1s informaci\u00f3n sobre el U.S. Agent?<\/p>\n<\/div><div style=\"text-align:center;\"><a class=\"fusion-button button-flat fusion-button-default-size button-custom fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" style=\"--button_accent_color:#ffffff;--button_accent_hover_color:var(--awb-custom12);--button_border_hover_color:var(--awb-color1);--button-border-radius-top-left:10px;--button-border-radius-top-right:10px;--button-border-radius-bottom-right:10px;--button-border-radius-bottom-left:10px;--button_gradient_top_color:var(--awb-custom12);--button_gradient_bottom_color:var(--awb-custom12);--button_gradient_top_color_hover:var(--awb-color1);--button_gradient_bottom_color_hover:var(--awb-color1);--button_text_transform:var(--awb-typography4-text-transform);--button_font_size:var(--awb-typography4-font-size);--button_line_height:var(--awb-typography4-line-height);--button_typography-letter-spacing:var(--awb-typography4-letter-spacing);--button_typography-font-family:&quot;Montserrat&quot;;--button_typography-font-style:normal;--button_typography-font-weight:700;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/es\/contactanos\/\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">CONT\u00c1CTENOS<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-27775","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>US Agent - Thema - Medical Regulatory Consultancy<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link 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